
Posted 17 hours ago
Clinical Evaluation Manager
Cochlear
Requirements
Degree in life sciences, medicine, audiology, or clinical research, Experience in scientific or technical roles, People leadership experience, Understanding of clinical evidence generation, Knowledge of regulatory expectations
Skills
Clinical ResearchMedical WritingRegulatory Affairs
About the role
Responsibilities
- Lead the planning, assignment, and delivery of clinical evidence and scientific dissemination assets across the Clinical Evaluation team
- Ensure the timely delivery of Clinical Evaluation Plans, Clinical Evaluation Reports, SSCPs, systematic literature reviews, and manuscripts
- Maintain scientific integrity, consistency, and traceability across all clinical assets throughout their lifecycle
- Ensure compliance with internal quality procedures and applicable global regulatory requirements
- Support audits and inspections by maintaining inspection-ready documentation
- Drive continuous improvement in documentation templates, workflows, and practices
- Partner with Regulatory, Quality, Medical Engagement, and study teams to align priorities
- Oversee external writing vendors, providing direction, review, and performance feedback
Requirements
- Degree in life sciences, medicine, audiology, clinical research, or a related discipline
- Proven experience in scientific or technical roles with an understanding of clinical evidence generation and regulatory expectations
- Demonstrated people leadership experience, including coaching and developing geographically dispersed teams
- Strong organizational and prioritization skills within a high-volume, highly regulated environment
- Ability to balance meticulous attention to detail with efficient delivery
Preferred Qualifications
- Experience delivering clinical evaluation or scientific evidence documentation in a regulated environment
- Familiarity with implantable medical devices or hearing health
- Experience coordinating vendor-supported medical writing or evidence delivery
About the Company
Cochlear is the global leader in implantable hearing solutions. Our mission is to help people hear and be heard, empowering individuals to connect with others and live full lives. We innovate to transform the way people understand and treat hearing loss, providing life-changing technology to people of all ages worldwide.
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Cochlear · Sydney
